NUDIST LIP BUTTER AFTERGLOW- zinc oxide stick

NUDIST LIP BUTTER by

Drug Labeling and Warnings

NUDIST LIP BUTTER by is a Otc medication manufactured, distributed, or labeled by ROYAL COSMETICS CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Zinc Oxide 10%

Purpose

Sunscreen

Uses

 Helps prevent sunburn.

Warnings

• For external use only.
• Do not use on damaged or broken skin.
• Stop use and ask doctor if skin rash occurs.
• When using this product keep out of eyes. Rinse with water to remove. 
• Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

Apply liberally to the lips. 

Sun Protection Measures 

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad

Spectrum SPF value of 15 or higher and other sun protection measures including:

Limit time in the sun, especially from 10 a.m. – 2 p.m.

Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients

Castor Isostearate Succinate, Acacia Decurrens/Jojoba/Sunflower Seed Wax/Polyglyceryl-Esters, Tribehenin, Oleic/Linoleic/Lonolenic
Polyglycarides, Euphorbia Cerifera (Candelila) Wax*, Simmondsia Chinensis (Jojoba) Oil*, Helianthus Annuus (Sunflower) Seed Oil*,
Rubus Idaeus (Red Raspberry) Seed Oil*, Daucus Carota Sativa (Carrot) Seed Oil*, Mixed Tocopherols, Camellia Sinensis Leaf Extract*,
Mentha Spicata (Spearmint)*, Vanilla Planifolia Fruit*. [± Iron Oxide (CI 77491, 77492, 77499), D & C Red 33 (CI 17200), D&C Red No. (CI
15850), Manganese Violet (CI 77742), Mica (CI 77019)

*ORGANIC INGREDIENTS

Other Information

Protect this product from excessive heat and direct sun. This is a water reisstant product.

Questions?

www.W3LLPEOPLE.com

Product Label

INGREDIENTS AND APPEARANCE

NUDIST LIP BUTTER  AFTERGLOW
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67597-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ACACIA DECURRENS FLOWER (UNII: 8PHF3LSM61)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
JOJOBA OIL (UNII: 724GKU717M)
CANDELILLA WAX (UNII: WL0328HX19)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
ISOSTEARIC ACID (UNII: X33R8U0062)
SUCCINIC ACID (UNII: AB6MNQ6J6L)
CASTOR OIL (UNII: D5340Y2I9G)
SUNFLOWER OIL (UNII: 3W1JG795YI)
RASPBERRY SEED OIL (UNII: 9S8867952A)
CARROT SEED OIL (UNII: 595AO13F11)
TOCOPHEROL (UNII: R0ZB2556P8)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MENTHA SPICATA OIL (UNII: C3M81465G5)
VANILLA BEAN (UNII: Q74T35078H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67597-001-01	1 in 1 CARTON	02/14/2020
1		2 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/14/2020

Labeler - ROYAL COSMETICS CORPORATION (616109799)

Establishment
Name	Address	ID/FEI	Business Operations
ROYAL COSMETICS CORPORATION		616109799	manufacture(67597-001)